NCT04378920

A Study of Liposomal Trans Crocetin, LEAF-4L6715, in Patients With Acute Respiratory Distress Syndrome Due to COVID-19, Sepsis or Other Causes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Institut de cancérologie Strasbourg Europe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label phase II study of treatment with LEAF-4L6715 in patients who experience severe acute respiratory distress syndrome (ARDS) due to COVID-19, Sepsis or other Causes. The purpose of this study is to evaluate the improvement in PaO2/FiO2 by more than 25% in patients treated with LEAF-4L6715.

Detailed description

Patient is treated with LEAF-4L6715, a liposomal transcrocetin. The liposomal formulation allows for a gradual release of the free drug, thereby facilitating less frequent dosing. Pharmacokinetic assessment will be carried out to identify an optimal dose and schedule.

Conditions

• COVID19, Sepsis or Other Causes
• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	LEAF-4L6715	LEAF-4L6715

Timeline

• Start date: 2020-04-14
• Primary completion: 2021-08-24
• Completion: 2021-08-24
• First posted: 2020-05-07
• Last updated: 2021-12-16

Locations

2 sites across 1 country: France

Regulatory

• FDA-regulated drug study